Kornimate/medical-research-clean huggingface dataset:
abdominal ct to predict the risk of acute graft-versus-host disease following allogeneic hematopoietic stem cell transplantation

Conditions: Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic; Multiple Myeloma

Summary: contrast-enhanced abdominal ct will be performed 1-2 weeks after allogeneic stem cell transplant, and radiographic evidence of mucosal inflammation will be correlated with the subsequent development of acute graft versus host disease. the primary endpoint is the feasibility and safety of contrast-enhanced abdominal ct in the early post-transplant period, as defined by the risk of contrast-related nephropathy or allergic reaction.


Eligibility criteria:
inclusion criteria: * biopsy-proven diagnosis of a hematologic malignancy * scheduled to undergo allogeneic sct from a matched sibling donor or an unrelated donor who is 10/10 or 9/10 hla match. transplant eligibility is per standard and institutional criteria. * age 18-60 years * willing and able to provide informed consent exclusion criteria: * documented or reported contrast allergy * estimated glomerular filtration rate (gfr) \< 60 * deemed too sick by clinician to leave the floor for imaging * "nothing-per-mouth" status for other clinical reasons inclusion of women and minorities -both men and women and members of all races and ethnic groups are eligible for this trial.
comparative outcomes related to delivery-room cord milking in low-resourced kountries- preterm

Conditions: Preterm; Infant Death

Summary: the goal of this multicenter, cluster-randomized, crossover trial is to determine if umbilical cord milking compared to early cord clamping will reduce in-hospital mortality in non-vigorous preterm infants born between 30 weeks and 34 weeks of gestation.

background: prematurity is the leading cause of death in children younger than 5 years of age. worldwide, 15 million infants are born premature, and india alone contributes to quarter of them. approximately 1 million children die each year due to complications of prematurity. delayed cord clamping (dcc), one of the methods of transfer of placental blood to neonates (placental transfusion) immediately after birth reduce mortality by 30% in premature infants. but dcc is not recommended in neonates who require immediate resuscitation. umbilical cord milking (ucm) is an option for placental transfusion in preterm infants who require immediate resuscitation but not currently recommended due to lack of randomized clinical trials. hypothesis: ucm will reduce the in-hospital mortality in non-vigorous preterm infants born between 30 weeks to 34 weeks of gestation compared to early cord clamping. methods: this multicenter cluster crossover randomized trial will enroll approximately 800 preterm infants to early cord clamping or milking the intact cord 4 times prior to clamping. impact: if investigators find that ucm is beneficial, this simple, low-tech, no cost intervention can be used in preventing deaths in preterm infants. this trial will potentially provide evidence to support a change in guidelines making ucm part of standard practice worldwide for preterm infants who require immediate resuscitation.

Eligibility criteria:
inclusion criteria: * preterm infants born between 30 0/7 weeks to 34 6/7 weeks of gestation * non-vigorous at birth exclusion criteria: * infants with congenital malformation * major chromosomal abnormalities * complete placental abruption/cutting through the placenta at the time of delivery * cord conditions (umbilical knots, inadequate cord length, cord rupture, non-reducible nuchal cord) * mono-chorionic twins, * twins with no information on amnion/chorion * multiple gestation \>2

Keywords: preterm umbilical cord milking placental transfusion
metabolomics explores biomarkers for metastatic breast cancer

Conditions: Breast Cancer

Summary: rationale: studying samples of plasm by metabolomics-based approach from women with metastasis breast cancer may help doctors understand the biomarker of visceral metastasis. purpose: this clinical trial is studying the biomarker of visceral metastasis by metabolomics approach in metastasis breast cancer undergoing treatment.

imaging evaluation of the effect of chemotherapy on patients with visceral metastases from breast cancer, metabolomics was used to analyze the changes of metabolites in plasma, and to find biomarkers that could reflect visceral metastasis and treatment effects. the purpose is to help clinicians predict whether patients have potential visceral metastases, evaluate the effects of visceral metastasis treatment, and reflect the patient's prognosis. patients with visceral metastases on imaging examinations received chemotherapy as planned, and blood samples were collected from patients before and during imaging assessments. analysis of metabolites in plasma using ultra high performance liquid chromatography. patient information were collected through medical record, including race, age, height and body mass index, menarche age, menstrual status, menopausal age (if applicable), tobacco and alcohol history, motherhood history, family history, etc.

Eligibility criteria:
inclusion criteria: * age: 18-70 yrs. * any menopausal status. * any hormone receptor status. * patients must have histologically or imaging confirmed breast cancer with visceral metastatic. * patients must have measurable disease, per recist criteria v1.1.21. * estimated life expectancy of ≥ 12 weeks. * ability to swallow oral medications. * participants must have adequate organ function as defined by: 1. anc ≥1.5 x 109/l, platelet count ≥100 x 109/l, haemoglobin ≥ 10 g/dl. 2. creatinine \< 1.5 x unl (upper normal limit). 3. total bilirubin \< 1.5x unl. 4. alt \& ast \< 2.5xunl; alkaline phosphatase \< 2.5xunl. 5. creatine phosphokinase (cpk) ≤ 2.5 x unl. * patients with cns metastatic disease are allowed if the disease is controlled and stable for at least 3 months by ct or mri. exclusion criteria: * current severe, uncontrolled systemic disease (e.g. pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures). * history of other malignancies. * no measureable lesion is present, as defined by recist 1.1. * patients who suffer from a medical or psychiatric condition that, in the opinion of the principal investigator, would impair their ability to participate in the study. * concurrent interventional studies.

Keywords: metastatic breast cancer metabolomics biomarkers clinical study
inspiratory muscle training in ehlers danlos patients

Conditions: Ehlers Danlos

Summary: evaluation of the effect of inspiratory muscle training in ehlers danlos patients


Eligibility criteria:
inclusion criteria: * a diagnosis for ehlers danlos syndrome combining genetics and clinical examination * no infectious exacerbation in the last four weeks exclusion criteria: * respiratory comorbidities
effect of pregabalin treatment in patients with diabetic nerve pain who currently use a non-steroid anti-inflammatory drug (nsaid) for another pain

Conditions: Painful Diabetic Peripheral Neuropathy

Summary: this study is to test the effectiveness of pregabalin in treating nerve pain caused by diabetes. the suitable subjects will be patients who also use an non-steroid anti-inflammatory drug for another pain which is not related to the diabetic nerve pain.


Eligibility criteria:
inclusion criteria: * type 1 or 2 diabetes with painful neuropathy * currently treated with one nsaid (including cox 2 inhibitors) for a co morbid pain condition with a regular dose * meet pre-defined level of pain severity at entrance exclusion criteria: * history of failed pregabalin treatment due to lack of efficacy at therapeutic dose * participated in a previous or ongoing pregabalin clinical trial * neurologic disorders unrelated to diabetic neuropathy that may confound the assessment of distal neuropathic pain
mental health econsults

Conditions: Mental Disorders

Summary: the purpose of this study is to assess whether electronic consultations between primary care providers and psychiatrists affects mental health services delivered in primary care settings.

this study assesses the effects of electronic consultations (econsults) between primary care providers and psychiatrists as a way to support the delivery of mental health services in primary care settings. the setting for the study are the primary care clinics of allina health. the study uses a randomized rollout design. across 45 primary care clinics, half of the clinics will be randomly assigned to receive access to econsults at the start of the study. the other half of the clinics will provide care-as-usual for nine months, at which point they will also gain access to econsults. stratified randomization will be used, with stratification on whether primary care clinics have co-located specialty mental health services. for primary care clinics that are given access to econsults, the primary care providers in those clinics will have the option of ordering an econsult on behalf of their patients, which will include specific questions about a particular patient's care. the request is routed to the service region's psychiatry pool, and the psychiatrists have the option of responding. if they choose to respond, the psychiatrist responds with their recommendations within one business day, and the pcp proceeds with care accordingly. the psychiatrist receives 0.75 work relative value units (wrvus) for providing this service. all communications for the econsult are routed through allina's epic system. although patients will not be billed for econsults over the course of the proposed research, some insurance plans do cover it and evidence of econsult effectiveness may impel other insurers to cover the service. the study will have two components. first, the investigators will collect web survey data from the primary care providers to assess how access to econsults affects providers' perceptions of their support and skill for delivering mental health services to their patients. second, the investigators will assess the effects of receiving econsults at the patient level, by using data from the electronic medical record system.

Eligibility criteria:
inclusion criteria: * for the provider surveys, we will recruit all of the primary care providers who work in allina's primary care clinics to participate in the surveys * for the patient-level analysis, we will examine data from all patients seen in allina's primary care clinics during the study period. we will include children and adults. exclusion criteria: * we will exclude patients from the patient-level analysis who have opted that their secondary data not be used by allina for research purposes.
targeted natural killer (nk) cell based adoptive immunotherapy for the treatment of patients with non-small cell lung cancer (nsclc) after radiochemotherapy (rct)

Conditions: NSCLC Stage IIIA/B

Summary: targeted natural killer (nk) cell based adoptive immunotherapy for the treatment of patients with non-small cell lung cancer (nsclc) after radiochemotherapy (rct)

patients with non-small cell lung carcinoma (nsclc) in stage iii a and iii b showing at least stable disease after rctx will be enrolled into the clinical trial. the aim of the study is to show the efficacy of an adjuvant treatment with hsp70-peptide tkd/il-2 activated, autologous nk cells following completion of standard radiochemotherapy (cisplatin/vinorelbine). patients will be randomized 1:1 either to the interventional study group to receive 4 cycles of autologous immunotherapy with activated nk cells or to the control group (bsc).

Eligibility criteria:
inclusion criteria: * first diagnosis of histologically and/or cytologically proven and unresectable nsclc with clinically stage iii a and iii b * completion of radiochemotherapy no longer than 8 weeks ago * progression free according to recist criteria at the first assessment after completion of rctx * confirmed presence of hsp70 on patient´s tumors * ecog status(appendices) ≤ 2 exclusion criteria: * any severe heart disease or any severe concomitant disease (ecog stage \> 2) * nsclc patients (stage iiia/b) eligible for initial surgery with a confirmed consent of an interdisciplinary tumorboard * patients that show alk positivity or an activating mutation of the egfr-tk domain * patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology * receipt of immunosuppressive drugs including high dose systemic corticosteroids within 3 weeks before study entry. low dose corticosteroids as they are a common treatment option for patients suffering from copd are not an exclusion criterium

Keywords: not eligible for surgery efficacy of immunotherapy following rctx
protein-energy enriched milk for infants with bronchiolitis

Conditions: Bronchiolitis

Summary: the aim of this study is to investigate if a standardized nutritional intervention with a protein and energy enriched milk could help overcome the catabolic state in children hospitalized with a bronchiolitis and thus creating a better nutritional state during hospitalization and at outpatient follow-up. the investigators also want to assess the clinical repercussion on the number of hospitalization days, the duration of oxygen support and the quality of life at ouptatient follow-up.

in this study, the investigators aim to assess the effect protein-energy enriched milk to reverse the catabolic state (weight loss, change in mid-upper arm circumference and tricpes skin fold) on the short term and failure to thrive (degree of weight recovery, change in arm circumference) one week after discharge in infants with moderate to severe bronchiolitis. the secondary short term aims are to investigate the effect on the length of hospital stay, days of oxygen support and the rate of antibiotic use. secondary long term outcomes are the re-admission rate, the persistence of wheezing and the number of work days missed by the parents. the investigators hypothesize that in those children who received a protein-energy enriched milk during hospitalization the catabolic state will be reversed more quickly by the intervention and will need less hospitalisation days, less oxygen support, less antibiotic use, less re-admission rate, less persistent wheezing and less work days missed by the parents. the investigators also hypothesize that the effects of the nutritional intervention on the proposed outcome parameters will be greater in children screened at high nutritional risk.

Eligibility criteria:
inclusion criteria: * all children hospitalized at the paediatric wards of uz brussel with the diagnosis of moderate to severe bronchiolitis * not meeting their normal oral intake are eligible for inclusion between the beginning of december and the end of february 2014 * bronchiolitis will be defined as a constellation of clinical symptoms and signs that typically begin with rhinitis and cough, and may progress to tachypnea, wheezing, rales, use of accessory muscles and/or nasal flaring exclusion criteria: * children admitted to the paediatric intensive care unit * children in whom it is unsafe to place a nasogastric tube (e.g. severe mucositis, platelet count \<50.000/µl) * children unwilling or unable to participate * children that are breast fed * children over the age of 12 months * children with an underlying malabsorption disease

Keywords: child, hospitalized nutritional status
prognostic value of angio-imr in hypertrophic cardiomyopathy patients

Conditions: Hypertrophic Cardiomyopathy

Summary: coronary microvascular dysfunction (cmd) is among pathophysiological states of significance in hypertrophic cardiomyopathy (hcm). the index of microcirculatory resistance (imr) has been recognized as an indicator of cmd and considered of important prognostic value in various conditions. the angiography-derived index of microcirculatory resistance (angio-imr) is a novel guidewire-free method to assess imr and proved to have favourable correlation with it. this study was designed to assess prognostic impact of cmd in hcm patients, using angio-imr as a novel non-invasive assessment tool.

coronary microvascular dysfunction (cmd) is among pathophysiological states of significance in hypertrophic cardiomyopathy (hcm). the index of microcirculatory resistance (imr) has been recognized as an indicator of cmd and considered of important prognostic value in various conditions. the angiography-derived index of microcirculatory resistance (angio-imr) is a novel guidewire-free method to assess imr and proved to have favourable correlation with it. in this study, patients who met the inclusion criteria were collected from two centers, and the angio-imr of three coronary arteries was measured to monitor their microcirculation. then, explore the prognostic value of the angio-imr of the left anterior descending artery (lad). at the same time combined with the sum of three coronary arteries' angio-imr, analysis of its prognostic value. in conclusion, this study was designed to assess prognostic impact of cmd in hcm patients, using angio-imr as a novel non-invasive assessment tool.

Eligibility criteria:
inclusion criteria: 1. diagnosed with hypertrophic cardiomyopathy(hcm) based on clinical guidelines 2. have qualified image for analysis of angio-imr exclusion criteria: 1）referred to hospital due to st-segment elevation myocardial infarction(stemi), heart failure and cardiopulmonary arrest; 2) implantation of any des or dcb; 3）severe valve dysfunction; 4）history of implantation of implantable cardioverter-defibrillator or pacemaker, septal myectomy or septal myocardial ablation; 5）meet the criteria of implantation of implantable cardioverter-defibrillator or pacemaker, septal myectomy or septal myocardial ablation; 6）impaired life-span expectancy due to cancer or other clinical conditions；
safety and efficacy trial to evaluate the hydrus(tm) implant in subjects undergoing cataract surgery.

Conditions: Primary Open Angle Glaucoma; Glaucoma, Open Angle, Pseudo-exfoliative; Cataract Unilateral Pending Extraction

Summary: the objective of this study is to demonstrate the ability of the hydrus implant to lower intraocular pressure in glaucoma patients undergoing cataract surgery.

this is a post-market, prospective, single-masked, randomized, controlled, multicenter clinical trial comparing cataract extraction (ce) surgery + hydrus implant vs ce surgery alone for the reduction of intraocular pressure (iop) in patients with a positive diagnosis for open angle glaucoma (poag) or pseudoexfoliative glaucoma. eligible patients will be scheduled for cataract surgery. at the time of the procedure, qualified subjects will be randomized into 1 of 2 treatment groups: hydrus implant with cataract surgery or cataract surgery alone. post-operative follow up will be conducted at regular intervals.

Eligibility criteria:
inclusion criteria: * diagnosis of primary open angle glaucoma or pseudoexfoliative glaucoma. * operable, age-related cataract eligible for phacoemulsification. exclusion criteria: * closed angle and narrow angle forms of glaucoma. * other secondary glaucoma, (such as neovascular, uveitic, traumatic, steroid induced, lens induced); glaucoma associated with increase episcleral venous pressure; congenital or developmental glaucoma.

Keywords: poag pxg iol surgery ce surgery
renal denervation in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus; Renal Denervation

Summary: sympathetic overactivity induces insulin resistance and type 2 diabetes mellitus (t2dm), so we assume that renal denervation (rdn) might improve glucose metabolism and insulin sensitivity. the purpose of this study is to evaluate the effects of multi-electrode catheter-based rdn on glucose metabolism and insulin sensitivity in patients with t2dm.

sympathetic overactivity induces insulin resistance and type 2 diabetes mellitus (t2dm), so it is assumed that renal denervation (rdn) might improve glucose metabolism and insulin sensitivity. some clinical studies have shown that glucose metabolism is improved in patients with resistant hypertension both 1 and 3 months after rdn, and fasting glucose, insulin and c-peptide decreased significantly as did insulin resistance assessed by homa-ir. but in some clinical studies, rdn did not lead to a significant improvement of insulin sensitivity ≤12 months after treatment, and no effect in systemic sympathetic activity was observed after rdn. therefore, the efficacy of rdn on glucose metabolism is still in controversy. the investigators wish to investigate the effect of multi-electrode catheter-based rdn on glucose metabolism and insulin sensitivity in patients with t2dm.

Eligibility criteria:
inclusion criteria: * over 18 years and ≤ 70 years old * able and willing to provide informed consent * patients with established type ii diabetes mellitus (hba1c\>7.5%, diet or oral hypoglycaemic agents) * clinical stable as demonstrated by no change in background anti-diabetic medication in the last 30 days. * anticipated that patients are able to maintain a stable dose of medication for the duration of the study exclusion criteria: * renal arterial anatomy ineligible for rdn: main renal arteries \<4 mm in diameter or \<20 mm in treatable length; multiple renal arteries where main renal artery is estimated to supply \<75% of the kidney * history of prior renal artery intervention including balloon angioplasty, stenting or previous renal denervation * type 1 diabetes mellitus * pregnant, nursing or planning to be pregnant * orthostatic hypotension * egfr \<30 ml/min (mdrd formula) * patients that have allergy to contrast agent * myocardial infarction, unstable angina pectoris, coronary bypass or percutaneous angioplasty within 3 months before inclusion * cerebrovascular accidents and alimentary tract hemorrhage within 3 months before inclusion * any medical condition which, in the investigators opinion, may adversely affect the participants safety in the trial
study on prevention, treatment and mechanism of preterm labor for chinese pregnant women ≥35 years old

Conditions: Preterm Labor

Summary: in china, there's no effective prevention and treatment on preterm birth for pregnant women ≥35 years old, so this study is necessary.

because the policy of "two-child" in china, there are more and more women more than 35 years old choose to have another baby. it is necessary to find out a way to prevent them who is older than 35 from preterm labor. about 1500 pregnant women will be recruited at about gestational age of 14 weeks for this study. all of them will be taken samples (i.e. blood, hair, cervical secretion ) to be saved before and after delivery. after all data collected, the investigators will do analysis of all data and find out strategy and mechanism of preterm labor.

Eligibility criteria:
inclusion criteria: * chinese pregnant women ≥ 35 years old exclusion criteria: * twins or multiple pregnancies, indicated preterm birth, \<35 years old, gestational ages ≥ 37 weeks, incomplete data of prenatal care。

Keywords: preterm labor china pregnant women ≥35 years old
comparison of visual field assessments between three perimeters

Conditions: Glaucoma

Summary: a single center, prospective, randomized, comparative study of visual field assessments between the tempo, visuall, and hfa perimeters. subjects will be assessed at 1 visit. clinical evaluations will include md, psd, ft, vfi, oct, and a questionnaire.


Eligibility criteria:
inclusion criteria: * adult patients with best-corrected visual outcomes of 20/30 or better. exclusion criteria: * unable to tolerate ophthalmic imaging * any ocular or systemic conditions, that could affect vf test results, such as age-related macular degeneration, peripheral retinal disease, or severe glaucoma. the principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.